Ilan Gruenwald

Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction.

BACKGROUND Low-intensity extracorporeal shockwave therapy (LI-ESWT) is currently under investigation regarding its ability to promote neovascularization in different organs. OBJECTIVE To evaluate the effect of LI-ESWT on men with erectile dysfunction (ED) who have previously responded to oral phosphodiesterase type 5 inhibitors (PDE5-I). DESIGN, SETTING, AND PARTICIPANTS We screened 20 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 5-19 (average: 13.5) and abnormal nocturnal penile tumescence (NPT) parameters. Shockwave therapy comprised two treatment sessions per week for 3 wk, which were repeated after a 3-wk no-treatment interval. INTERVENTION LI-ESWT was applied to the penile shaft and crura at five different sites. MEASUREMENTS Assessment of erectile function was performed at screening and at 1 mo after the end of the two treatment sessions using validated sexual function questionnaires, NPT parameters, and penile and systemic endothelial function testing. The IIEF-ED questionnaire was answered at the 3- and 6-mo follow-up examinations. RESULTS AND LIMITATIONS We treated 20 middle-aged men (average age: 56.1 yr) with vasculogenic ED (mean duration: 34.7 mo). Eighteen had cardiovascular risk factors. At 1 mo follow-up, significant increases in IIEF-ED domain scores were recorded in all men (20.9 +/- 5.8 vs 13.5+/- 4.1, p<0.001); these remained unchanged at 6 mo. Moreover, significant increases in the duration of erection and penile rigidity, and significant improvement in penile endothelial function were demonstrated. Ten men did not require any PDE5-I therapy after 6-mo follow-up. No pain was reported from the treatment and no adverse events were noted during follow-up. CONCLUSIONS This is the first study that assessed the efficacy of LI-ESWT for ED. This approach was tolerable and effective, suggesting a physiologic impact on cavernosal hemodynamics. Its main advantages are the potential to improve erectile function and to contribute to penile rehabilitation without pharmacotherapy. The short-term results are promising, yet demand further evaluation with larger sham-control cohorts and longer follow-up.

Normative values for female genital sensation.

OBJECTIVES Neurologic disorders might be responsible for many cases of female sexual dysfunction. Yet, they are currently undiagnosed because of the lack of measurement tools to assess genital neural function. Therefore, our objective is to provide norms for sensory thresholds in the vagina and clitoris, for a wide range of patient ages. METHODS Vaginal and clitoral warm, cold, and vibratory sensory thresholds were measured in 89 healthy paid volunteers by the method of limits. Normograms were derived from this group of healthy volunteers. An additional 61 patients were also tested, for a total of 150 individuals. Sixty-two individuals (42 healthy volunteers and 20 patients) from the total group were tested twice to provide test-to-test repeatability data across the range of clinical (normal and abnormal) responses. RESULTS Normograms are presented, providing age-corrected upper and lower normal values, expressed as 95% confidence limits for warm, cold, and vibratory thresholds. Intertest repeatability is also reported. CONCLUSIONS Thermal and vibratory thresholds of both the vaginal and clitoral region are clinically feasible, valid, and repeatable. These can be applied as a valuable diagnostic tool to assess neural dysfunction through sensory assessment of the female genitalia.

Vulvar vestibulitis severity—assessment by sensory and pain testing modalities

&NA; Vulvar vestibulitis syndrome (VVS) is a common cause of dyspareunia in pre‐menopausal women. Previous quantitative sensory test (QST) studies have demonstrated reduced vestibular pain thresholds in these patients. Here we try to find whether QST findings correlate to disease severity. Thirty‐five vestibulitis patients, 17 with moderate and 18 with severe disorder, were compared to 22 age matched control women. Tactile and pain thresholds for mechanical pressure and thermal pain were measured at the posterior fourcette. Magnitude estimation of supra‐threshold painful stimuli were obtained for mechanical and thermal stimuli, the latter were of tonic and phasic types. Pain thresholds were lower and supra‐threshold magnitude estimations were higher in VVS patients, in agreement with disease severity. Cut‐off points were defined for results of each test, discriminating between moderate VVS, severe VVS and healthy controls, and allowing calculation of sensitivity and specificity of the various tests. Our findings show that the best discriminative test was mechanical pain threshold obtained by a simple custom made ‘spring pressure device’. This test had the highest &kgr; value (0.82), predicting correctly 88% of all VVS cases and 100% of the severe VVS cases. Supra‐threshold pain magnitude estimation for tonic heat stimulation also had a high &kgr; value (0.73) predicting correctly 82% overall with a 100% correct diagnosis of the control group. QST techniques, both threshold and supra‐threshold measurements, seem to be capable of discriminating level of severity of this clinical pain syndrome.

Low-Intensity Extracorporeal Shock Wave Therapy—A Novel Effective Treatment for Erectile Dysfunction in Severe ED Patients Who Respond Poorly to PDE5 Inhibitor Therapy

INTRODUCTION Low-intensity shock wave therapy (LI-ESWT) has been reported as an effective treatment in men with mild and moderate erectile dysfunction (ED). AIM The aim of this study is to determine the efficacy of LI-ESWT in severe ED patients who were poor responders to phosphodiesterase type 5 inhibitor (PDE5i) therapy. METHODS This was an open-label single-arm prospective study on ED patients with an erection hardness score (EHS) ≤ 2 at baseline. The protocol comprised two treatment sessions per week for 3 weeks, which were repeated after a 3-week no-treatment interval. Patients were followed at 1 month (FU1), and only then an active PDE5i medication was provided for an additional month until final follow-up visit (FU2). At each treatment session, LI-ESWT was applied on the penile shaft and crus at five different anatomical sites (300 shocks, 0.09 mJ/mm(2) intensity at 120 shocks/min). Each subject underwent a full baseline assessment of erectile function using validated questionnaires and objective penile hemodynamic testing before and after LI-ESWT. MAIN OUTCOME MEASURES Outcome measures used are changes in the International Index of Erectile Function-erectile function domain (IIEF-ED) scores, the EHS measurement, and the three parameters of penile hemodynamics and endothelial function. RESULTS Twenty-nine men (mean age of 61.3) completed the study. Their mean IIEF-ED scores increased from 8.8 ± 1 (baseline) to 12.3 ± 1 at FU1 (P = 0.035). At FU2 (on active PDE5i treatment), their IIEF-ED further increased to 18.8 ± 1 (P < 0.0001), and 72.4% (P < 0.0001) reached an EHS of ≥ 3 (allowing full sexual intercourse). A significant improvement (P = 0.0001) in penile hemodynamics was detected after treatment and this improvement significantly correlated with increases in the IIEF-ED (P < 0.05). No noteworthy adverse events were reported. CONCLUSIONS Penile LI-ESWT is a new modality that has the potential to treat a subgroup of severe ED patients. These preliminary data need to be reconfirmed by multicenter sham control studies in a larger group of ED patients.

Sexual dysfunction in females with multiple sclerosis: quantitative sensory testing

Introduction and objectives Female sexual dysfunction (FSD) is highly prevalent (45–74%) in multiple sclerosis (MS) patients. Quantitative sensory testing (QST) has recently been used to assess normal neural function of the female genitalia. In this study we used QST for assessment of the genital neural function of female MS patients. Materials and methods We examined 41 female MS patients aged 21–56, with 10 years median disease duration. Each patient had a neurological examination, and evaluation of sexual function (SF) by both questionnaire and a focused interview. QST wasperformed at the clitoris and vagina for temperature and vibratory stimuli, by method of limits. Results By questionnaire, 25 patients (61%) had FSD; the most common complaints were decreased libido (61%) and orgasmic disturbances (54%). Sensory deficit was very common–significant correlations were found between high sensory thresholds and FSD parameters; the most significant correlation was between clitoral vibratory sensation and orgasmic dysfunction (r=0.423, P=0.006). Another interesting significant association was found between cerebellar deficit and orgasmic dysfunction (P=0.0012). Conclusions This study suggests that QST of the genitalia, specifically clitoral vibration, may be a useful test for detecting sexual dysfunction in MS patients, and supports an important role of the cerebellum in SF.

Effects of sildenafil citrate (viagra) on blood pressure in normotensive and hypertensive men.

OBJECTIVES To determine the occurrence of clinically significant decreases in blood pressure (BP) with sildenafil use in normotensive and hypertensive men by means of ambulatory BP monitoring. METHODS On 2 nights, 49 men (22 hypertensive, 27 normotensive) had their ambulatory systolic BP (SBP), diastolic BP (DBP), and heart rate monitored during the first 3 hours (waking period) and every 30 minutes after midnight for 3 additional hours (sleeping period). No medication was taken on one night; sildenafil 100 mg was taken on the other. RESULTS Sildenafil decreased SBP (-6.0 mm Hg; P = 0.0003), DBP (-4.5 mm Hg; P = 0.001), and mean arterial pressure (-5.3 mm Hg; P = 0.00008). The BP-lowering effects of sildenafil did not differ significantly in the normotensive and hypertensive men. Age significantly affected the BP reductions; decreases in SBP, DBP, and mean arterial pressure were greater in men 49 years old and older than in those younger than 49 years old. According to readings averaged over the entire control and treatment periods, 22.7% of hypertensive men and 3.7% of normotensive men experienced SBP reductions of 20 mm Hg or greater (P = 0.08 for comparison of the two groups); the respective values for DBP were 9.1% and 3.7% (P not significant). These reductions were not associated with any hypotensive symptoms. All participants tolerated sildenafil well. CONCLUSIONS Sildenafil caused small, clinically insignificant reductions in ambulatory BP in active and resting normotensive and hypertensive men. The results of this study suggest that, when used in accordance with the prescribing information and current treatment guidelines, sildenafil should be safe in younger and older men with or without hypertension.

A Critical Analysis of Penile Enhancement Procedures for Patients with Normal Penile Size: Surgical Techniques, Success, and Complications

CONTEXT Most men who request surgical penile enhancement have a normal-sized and fully functional penis but visualize their penises as small (psychological dysmorphism). OBJECTIVES The aim of this review is to describe the various reported techniques and to provide the available scientific data on the success and complication rates of penile enhancement procedures. EVIDENCE ACQUISITION We performed an extensive systematic review based on a search of the MEDLINE database for articles published between 1965 and 2008. The following key words were used: penis, enhancement, enlargement, phalloplasty, reconstruction, girth, lengthening, and augmentation. Only English-language articles that were related to penile surgery and dysmorphobia were sought. We excluded articles in which fewer than five cases were described and articles in which the type of surgical treatment and the outcome were not clear. Of the 176 papers found, 34 were selected and critically analyzed. EVIDENCE SYNTHESIS We found only a small number of well-designed and comprehensive studies, and most of the published articles reported data that were obtained from small cohorts of patients. The more recently published studies presented better methodologies and descriptions of the surgical techniques than did the older publications. In general, penile enhancement surgery can cause a 1-2-cm increase in penile length and a 2.5-cm augmentation of penile girth. Unwanted outcomes and complications, namely penile deformity, paradoxical penile shortening, disagreeable scarring, granuloma formation, migration of injected material, and sexual dysfunction were reported frequently in these studies. Disappointing short- and long-term patient satisfaction rates following these procedures were also reported in most studies. CONCLUSIONS To date, the use of cosmetic surgery to enlarge the penis remains highly controversial. There is a lack of any standardization of all described procedures. Indications and outcome measures are poorly defined, and the reported complications are unacceptably high. In our opinion, until new, reliable, and more objective and reproducible data are available, these procedures should be regarded as investigational and patients should be discouraged from undergoing these invasive treatments.

Penile and Systemic Endothelial Function in Men with and without Erectile Dysfunction

BACKGROUND Assessment of endothelial function can provide essential information about the mechanisms of cardiovascular disease. Emerging data show that erectile dysfunction (ED) can precede the symptoms of ischemic heart disease, and this suggests that endothelial dysfunction is the link between these two clinical entities. OBJECTIVE To evaluate penile and systemic endothelial function in subjects with and without ED. DESIGN, SETTING, AND PARTICIPANTS Fifty-nine subjects were enrolled in the study. According to their International Index of Erectile Function (IIEF) ED domain scores, they were divided into two groups: 40 patients with ED and 19 men without ED (control group). Hemodynamic measurements, penile endothelial function, and forearm endothelial function were assessed in all participants using veno-occlusive plethysmography. MEASUREMENTS We measured baseline blood flow in both the forearm and the penis and calculated the corresponding vascular resistances. Postischemic changes in blood flow were recorded serially in both organs for the evaluation of endothelial function. Area under the flow-time curve (AUC), and maximal blood flow after ischemia were considered to be the indices of endothelial function. RESULTS AND LIMITATIONS General characteristics of the two groups of participants were comparable except for age (40.5+/-3.3 yr in the control group vs 53.3+/-2.3 yr in the ED group). Baseline forearm blood flow was similar in the two groups, but the penile blood flow was significantly lower in men with ED compared with that in the men without ED: 6.2+/-0.6 versus 8.6+/-0.6 ml/min per 100ml of tissue (p=0.006). Penile vascular resistance was higher in the ED group compared with the control group. The indices of forearm endothelial function were comparable in both groups (p=0.70 for the AUCs). However, indices of penile endothelial function were significantly higher in the control group compared with those of the ED group (AUC: 950 units+/-130 vs 450+/-80 units, p=0.001). CONCLUSIONS The use of veno-occlusive plethysmography for evaluating penile endothelial function is simple and reliable and provides new information on the pathophysiology of ED at the level of penile vasculature. This is the first study that provides evidence of impaired penile endothelial function without the presence of a significant peripheral endothelial dysfunction. Furthermore, these results provide further support for the notion that the development of ED could predict the future onset of cardiovascular disease.

Does the G-spot exist? A review of the current literature

In 1950, Gräfenberg described a distinct erotogenic zone on the anterior wall of the vagina, which was referred to as the Gräfenberg spot (G-spot) by Addiego, Whipple (a nurse) et al. in 1981. As a result, the G-spot has become a central topic of popular speculation and a basis of a huge business surrounding it. In our opinion, these sexologists have made a hotchpotch of Gräfenberg’s thoughts and ideas that were set forth and expounded in his 1950 article: the intraurethral glands are not the corpus spongiosum of the female urethra, and Gräfenberg did not report an orgasm of the intraurethral glands. G-spot amplification is a cosmetic surgery procedure for temporarily increasing the size and sensitivity of the G-spot in which a dermal filler or a collagen-like material is injected into the bladder–vaginal septum. All published scientific data point to the fact that the G-spot does not exist, and the supposed G-spot should not be identified with Gräfenberg’s name. Moreover, G-spot amplification is not medically indicated and is an unnecessary and inefficacious medical procedure.

Validation of a real-time urodynamic measure of urinary sensation

OBJECTIVE The purpose of this study was to test the feasibility and validity of a continuous measurement of urinary sensation during cystometry. STUDY DESIGN Subjects continuously recorded their level of urinary sensation during cystometry with the use of urodynamic diagnoses and responses to the Medical Epidemiologic and Social Aspects of Aging (MESA) and Urinary Distress Inventory (UDI) scales. Trends in urinary sensation recordings by increasing percentage of maximum cystometric capacity (MCC) were captured and compared with the use of growth curves. RESULTS Fifty-one women participated: 18 patients had detrusor overactivity incontinence (DOI); 15 patients had urodynamic stress incontinence; 9 patients had mixed incontinence, and 9 patients did not demonstrate incontinence. In the volume range between 35% and 75% of MCC, the mean sensation level was higher in the DOI group than the other groups (P < .04). Urge sensation at 50% of MCC correlated with UDI and MESA urge subscales (rho = 0.34, p < .03 and rho = 0.39, p < .02). CONCLUSION This study demonstrates that the Urgeometer measurement is feasible and correlates with urodynamic diagnosis and the severity and bother from urge incontinence.